Pyrotinib Combined With Trastuzumab Plus Aromatase Inhibitor in Treatment of Breast Cancer

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Status and phase: Unknown; Phase 2

Conditions: Breast Cancer Female; Breast Diseases; Hormone Receptor Positive Tumor; Hormone Receptor Positive Malignant Neoplasm of Breast; HER2-positive Breast Cancer; Metastatic Breast Cancer

Treatments: Drug: Aromatase Inhibitors; Drug: Trastuzumab; Drug: Pyrotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT04088110

Arise-FJ-B102

Details and patient eligibility

About

This study is a single-arm, open-label, phase II study, comparing the efficacy and safety of pyrotinib plus trastuzumab and aromatase inhibitors, in the treatment of HR (hormone receptor)+/HER2 (human epidermal growth factor receptor 2) + MBC and inoperable LABC patients.

Full description

This is a exploratory, single-arm, open-label,multicenter phase II trial. Our primary purpose is to compare that PFS of patients with pyrotinib plus trastuzumab and AI for HER2-positive and hormone receptor-positive MBC or locally advanced breast cancer (LABC).

In treatment period, patients will be administrated pyrotinib plus trastuzumab and aromatase inhibitors, every 21 days for 1 cycle, until disease progression, toxicity intolerance, withdrawal of informed consent, patients judged must be terminated study termination.

The imaging evaluation was performed according to the RECIST 1.1 criteria every 6 weeks.

Enrollment: 77 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age≥18 years,≤70 years, female;
2. Postmenopausal or pre-menopausal with ovarian function suppression;
3. with or without measurable lesion evaluable according to Response Evaluation Criteria In Solid Tumors Version 1.1;
4. Metastatic or inoperable local advanced Invasive breast cancer;
5. HER2-positive breast cancer;
6. HR-positive breast cancer;
7. LVEF ≥55%;QT interva<470 ms;
8. Eastern Cooperative Oncology Group(ECOG) scale 0-1;
9. Life expectancy ≥3 months;

Exclusion criteria

1. Previous systemic non-hormonal anticancer therapy in the metastatic or advanced breast cancer setting;
2. Received endocrine therapy within 7 days before randomization;Uncontrolled central nervous system metastases;
3. Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal treatment to recurrence of within 6 months.
4. Other malignancies within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
5. Major surgical procedure or significant traumatic injury within 28 days prior to study treatment start or anticipation of the need for major surgery during the course of study treatment
6. Severe organ dysfunction as assessed by signs and symptoms, laboratory studies and rapid progression of disease, which leading to a clinical indication for chemotherapy.
7. History of CHF of any New York Heart Association (NYHA) criteria, or serious cardiac arrhythmia requiring treatment (exception, atrial fibrillation, paroxysmal supraventricular tachycardia);
8. History of myocardial infarction within 6 months of randomization;
9. History of LVEF decline to below 50% during or after prior trastuzumab neo-adjuvant or adjuvant therapy;
10. Pregnant or lactating women;
11. QT interval>470 ms;
12. Serious concomitant diseases (including severe hypertension, severe diabetes, active infection, thyroid disease, etc.) that are harmful to the patient's safety or affect the patient's completion of the study;

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Pyrotinib and trastuzumab plus aromatase inhibito

Experimental group

Description:

Participants will receive pyrotinib in combination with trastuzumab plus AI until pre-defined study end, disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Treatment:

Drug: Pyrotinib

Drug: Aromatase Inhibitors

Drug: Trastuzumab